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Cenobamate manufacturers

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Country of origin : India

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5 products found

cenobamate

Tablets 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #17643
This company specializes in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates, focusing on cost-effective solutions with a strong emphasis on quality. They offer contract development and manufacturing services (CDMO) for both New Chemical Entities (NCEs) and APIs, leveraging their globally compliant GMP facilities and expertise in modified release technologies. The company boasts state-of-the-art production lines capable of handling high-potent materials across various scales, catering to a wide range of pharmaceutical products including prescription medications and potentially over-the-counter drugs. While specific therapy areas aren't mentioned, they hold patents for their innovations and are actively involved in research and development. Their operations span multiple regions, including North America and the EU.

Manufacturer usually replies in 2 days

cenobamate

Tablets 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #34252

Established in 2004, this vertically integrated pharmaceutical manufacturer is committed to delivering high-quality, affordable medicines globally. As a CTD dossier owner and manufacturer, it holds GMP certifications from the US FDA, EU, and WHO, ensuring compliance with stringent international quality standards. The company's state-of-the-art R&D center is capable of handling oral solids, liquids, and parenteral formulations. Its products have received marketing authorizations from regulatory authorities such as the US FDA, Health Canada, CDSCO-India, and New Zealand. With over 20 ANDA/ANDs under approval, the manufacturer operates advanced production lines adhering to rigorous GMP guidelines. Its diverse portfolio includes therapeutics in areas like antivirals, neurology, women's health, cardiology, and imaging contrast agents.

Manufacturer usually replies in 8 days

cenobamate

Tablets 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Xcopri®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

Manufacturer usually replies in 26 days

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